Shanghai Fanta Dental Materials Co., Ltd

Certificate DZ 2450210-1

Rev. Rev.1Supplemented

Valid until: Sep 4, 2029

Certificate DZ 2450210-1 is a valid Quality assurance issued to Shanghai Fanta Dental Materials Co., Ltd and registered in EUDAMED. Valid until September 4, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: DZ 2450210-1
Certificate type: Quality assurance
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197DZ 2450210-1Rev.1

Validity

Issued: Apr 20, 2026
Valid from: Apr 20, 2026
Valid until: Sep 4, 2029

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

DZ 2450210-1Quality assuranceIssuedSep 5, 2024 → Sep 4, 2029

Scope coverage

Class I1Class IIa1

2 scopes

L159004- ENDODONTIC RASPS AND FILES, REUSABLE - Endodontic Hand Instruments
Class I
L159004- ENDODONTIC RASPS AND FILES, REUSABLE - Root Canal Files Q010507 - ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE - Sterile Endodontic Hand Instruments - Sterile Root Canal Files
Class IIa

Documents

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